Device Recall Boston Scientific

Manufacturer

  • Manufacturer Address
    Boston Scientific Marlbourgh, 100 Fairbanks Blvd, Marlborough MA 01752-1234
  • Source
    USFDA

174 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot: 00112758, Use by 2018-05-11
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, FL, KY, MO, NM, OK, OR, PA, and TX.
  • Product Description
    Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
  • Manufacturer
  • Model / Serial
    Lot Numbers:  5175575 5185073 5185074 5185075 5193211 5193212 5193213 5193920 5196902
  • Product Classification
  • Distribution
    Nationwide
  • Product Description
    Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon || Catalog # 4545
  • Manufacturer
  • Model / Serial
    Pouch codes for the 180 cm length wuidewires are:  Catalog No. 46-591, UPN M001465910 Lot Number Use Before Date 4959940 2005-08 4959941 '' 4969651 '' 4969654 '' 4969655 '' 4969656 ''  The pouch codes for the 260 cm length guidewires are: Catalog No. 46-5912, UPN M001465920 Lot Number Use Before Date 4959945 2005-08 4959946 '' 4959944 '' 4959943 ''
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 118 hospitals nationwide.
  • Product Description
    Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.
  • Manufacturer
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